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The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments.
The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments. Briefly, 30 eligible participants will be randomized (1:1 ratio) to receive a single session of either simulated/sham or genuine/real chiropractic spinal adjustments and be given a brief survey immediately following their session and 48 hours later that captures their perceptions and experiences regarding the intervention they received. This study is intended to inform a future multi-session, randomized, sham-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genuine/real | Experimental | 15 participants receiving genuine/real chiropractic adjustment |
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| Simulated/sham | Sham Comparator | 15 participants receiving simulated/sham "adjustment" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic adjustment | Procedure | A single-session of genuine/real high-velocity, low-amplitude (HVLA) manual chiropractic adjustments to various regions of the spine (i.e., cervical, thoracic, lumbo-pelvic) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant blinding | The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding. | Immediately after intervention |
| Participant blinding | The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding. | 48 hours after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyson Perez, DC, PhD | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sid E. Williams Center for Chiropractic Research | Marietta | Georgia | 30067 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2024 | Jan 17, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D026882 | Manipulation, Chiropractic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Randomized, sham-controlled, proof-of-concept trial
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Single-blinded
| Sham adjustment | Procedure | A single-session of simulated/sham high-velocity, low-amplitude (HVLA) manual chiropractic adjustments to various regions of the spine (i.e., cervical, thoracic, lumbo-pelvic) |
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